Adams Respiratory files lawsuit against Perrigo for infringement of extended-release guaifenesin patent.

Adams Respiratory Therapeutics, Inc. (Chester, NJ) has filed a lawsuit in the United States District Court for the District of New Jersey against Perrigo Company, L. Perrigo Company and Perrigo Research and Development Company (collectively Perrigo), for infringement of Adams' United States Patent 6,372,252. The '252 patent, which relates to the company's Mucinex line of oral solid, extended-release guaifenesin products, expires in 2020 and is listed in the FDA Orange Book.

Adams filed the lawsuit in response to Perrigo's notification that it filed a Paragraph IV Certification in connection with its Abbreviated New Drug Application (ANDA), which seeks FDA approval to engage in the commercial manufacture, use or sale of guaifenesin 600 mg single-ingredient, extended-release tablets (equivalent to Adams' Mucinex SE), prior to the expiration of the '252 patent. This patent infringement lawsuit will automatically stay the FDA from approving Perrigo's ANDA until the earlier of 30 months or until a district court decision that is adverse to Adams.

Adams markets six patent-protected extended-release guaifenesin products over-the-counter under the Mucinex brand name, including a new line of 1200 mg maximum-strength products. These products are the only available FDA-approved extended-release guaifenesin products. Perrigo's ANDA relates only to guaifenesin 600 mg single-ingredient, extended-release tablets.

Adams plans to vigorously defend its market position for Mucinex as well as its patent portfolio protecting the company's oral solid, extended-release guaifenesin products.

Adams is a specialty pharmaceutical company focused on the late-stage development, commercialization and marketing of over-the-counter and prescription pharmaceuticals for the treatment of respiratory disorders.

Respiratory Therapeutics, Inc.

+1-908-879-2428

www.adamsrt.com